Status:
COMPLETED
Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children
Lead Sponsor:
ResMed
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
12-17 years
Brief Summary
The feasibility and the validity of the ApneaLink Air home sleep testing (HST) device will be tested in adolescent children. The ApneaLink Air HST device is cleared for the diagnosis of obstructive sl...
Detailed Description
Obstructive sleep apnea is highly prevalent in children affecting 2-3% of children and up to 10% of obese children. The reported prevalence is likely underestimated due to the lack of available labora...
Eligibility Criteria
Inclusion
- Patients presenting with symptoms of OSA needing a sleep study
- Patients between the ages of 12 and 17 years, inclusive
Exclusion
- Patients less than 12 years old
- Patients 18 years old or older
- Children with syndromes or congenital disease including Down Syndrome, Prader-Willi syndrome, children with craniofacial disorders, and finally children with congenital heart disease or pulmonary hypertension
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03748771
Start Date
December 1 2018
End Date
February 28 2020
Last Update
November 15 2021
Active Locations (1)
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1
Rady Children's Hospital
San Diego, California, United States, 92123